Accessible Hearing Care Interventions for Hearing Loss

Overseen By Marcia J Hay-McCutcheon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to make hearing care more affordable and accessible for adults with mild-to-moderate hearing loss, especially those without access to hearing healthcare. It involves three different approaches using over-the-counter hearing aids. One group will use the hearing aids independently, another will receive assistance with fitting and orientation (Personal Sound Amplification Product or PSAP fitting), and the last group will participate in a four-week aural rehabilitation (hearing improvement) program. Individuals with mild-to-moderate hearing loss living in West Central or South Alabama might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions in hearing care accessibility.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that over-the-counter (OTC) hearing aids are generally safe for adults with mild-to-moderate hearing loss. Studies have found only minor risks, with a small chance of hearing damage if used by individuals with normal hearing. This suggests that when used properly, OTC hearing aids are unlikely to cause harm.

Regarding aural rehabilitation, research indicates it can enhance the quality of life for those with hearing loss. No major safety concerns have been reported, suggesting it is well-tolerated.

Overall, both OTC hearing aids and aural rehabilitation appear to be safe options for most people. However, following the instructions and consulting a healthcare professional if there are any concerns is always wise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these hearing care interventions because they tackle hearing loss in an accessible and innovative way. Unlike traditional hearing aids that require professional fitting and orientation, the Over-the-Counter Only option empowers individuals to independently manage their hearing needs with readily available devices. The Audiology Best Practices arm enhances this by including professional fitting and orientation, improving the user experience and outcome. The Audiology Best Practices plus Aural Rehabilitation arm takes it a step further by incorporating a four-week aural rehabilitation program, potentially boosting auditory skills and quality of life even more. This trial is exploring the effectiveness of different levels of support and training, aiming to make hearing care more accessible and tailored to individual needs.

What evidence suggests that this trial's interventions could be effective for hearing loss?

Research has shown that programs to assist with hearing can significantly enhance life for individuals with hearing loss. They improve the effectiveness of hearing aids and make hearing feel easier. Studies also find that ear training can enhance speech comprehension, especially in noisy environments. In this trial, one group will receive over-the-counter (OTC) hearing aids without professional fitting, while another group will receive OTC hearing aids with professional fitting and orientation. A third group will receive both the professional fitting and a four-week aural rehabilitation program. Although evidence for OTC hearing aids is less clear, many users report positive experiences and feel less fatigued from listening when using these devices. Combining these treatments might make hearing care more accessible and effective for those with mild-to-moderate hearing loss. ^{1 6 7 8 9}

Who Is on the Research Team?

Marcia J Hay-McCutcheon, PhD

Principal Investigator

The University of Alabama, Tuscaloosa

Are You a Good Fit for This Trial?

This trial is for adults over 40 living in West Central or South Alabama who have mild-to-moderate hearing loss. It's not open to those with severe cognitive impairments from conditions like stroke, head injury, dementia, or Alzheimer's disease.

Inclusion Criteria

I am 40 years old or older.

I have some difficulty hearing.

You live in West Central or South Alabama.

Exclusion Criteria

I do not have severe cognitive issues from conditions like stroke or Alzheimer's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive over-the-counter hearing aids and participate in aural rehabilitation programs as per their assigned group

14 weeks

Multiple visits for hearing evaluations and interventions

Follow-up

Participants are monitored for changes in hearing aid outcomes and quality of life

1 year

Annual assessment

Extension

Participants who complete the study in years 1 and 2 are invited back for additional testing

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Four Weeks of Aural Rehabilitation
• Hearing Evaluation
• Personal Sound Amplification Product (PSAP) Fitting and Orientation
• Provision of Personal Sound Amplification Products (PSAPs)

Trial Overview The study tests three interventions: providing personal sound amplification products (PSAPs), a four-week aural rehabilitation program, and PSAP fitting/orientation alongside regular hearing evaluations to improve hearing healthcare access and affordability.

How Is the Trial Designed?

Group I: Audiology Best Practices plus Aural Rehabilitation (ABP+AR) Experimental Treatment 3 Interventions

This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.

Group II: Over-the-Counter Only (OTC-Only) Active Control 2 Interventions

This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.

Group III: Audiology Best Practices (ABP) Active Control 2 Interventions

This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.

Hearing Evaluation is already approved in United States for the following indications:

Approved in United States as OTC Hearing Aids for:

• Mild to moderate hearing loss in adults 18 years and older

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Some personal sound amplification products (PSAPs) can provide adequate amplification for common types of hearing loss, with two high-end PSAPs meeting all necessary electroacoustic tolerances in a controlled study.

In clinical tests, a representative PSAP (RPSAP) improved hearing compared to no device but performed slightly worse than conventional hearing aids, suggesting it may be a useful alternative for individuals with moderate hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Personal Sound Amplification Products in Patients With Moderate Hearing Loss: A Pilot Study. Kim, GY., Kim, JS., Jo, M., et al.[2022]

Over-the-counter hearing aids (OTC-HAs) and personal sound amplification products (PSAPs) showed larger deviations from amplification targets compared to prescription hearing aids (HAs), particularly for moderate to severe hearing loss, indicating they may be less effective for those with more significant hearing impairments.

For mild hearing loss, OTC-HAs and PSAPs could meet some prescriptive targets, but overall, half of these devices did not consistently perform well, suggesting that while they may be accessible, their efficacy compared to prescription devices is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss. Sheffield, SW., Jacobs, M., Ellis, C., et al.[2023]

Some direct-to-consumer hearing devices, like personal sound amplification products (PSAPs) and over-the-counter (OTC) hearing aids, can produce dangerously high sound levels, which may pose safety risks for users.

Despite lower satisfaction rates compared to professionally purchased hearing aids, OTC devices show potential benefits, especially when supported by hearing health care professionals, indicating a need for further research to better understand their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. Manchaiah, V., Taylor, B., Dockens, AL., et al.[2018]

The study revealed that the overall perception of personal sound amplification products (PSAPs) among 197 outpatient visitors was low, with a perception score of only 3.04 out of 5, indicating a need for better awareness and understanding of these devices.

There was a significant discrepancy in the expected price of PSAPs, with patients and caregivers expecting to pay around $933.9 per ear, while hearing specialists estimated the price to be much lower at $291.3 per ear, highlighting a gap in communication and expectations between these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception and expectations of personal sound amplification products in Korea: A hospital-based, multi-center, cross-sectional survey. Han, JS., Kim, Y., Park, MK., et al.[2022]

In a study involving 40 adults with mild to moderately severe hearing loss, 55% successfully completed the self-fitting procedure for commercially available hearing aids, indicating a moderate level of efficacy for these devices.

Errors during the self-fitting process varied by experience level, with experienced users making more mistakes related to the hearing test and fine-tuning, while new users struggled more with physical customization and insertion, suggesting that tailored support and improved instructions could enhance user success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Self-Fitting Process with a Commercially Available Hearing Aid. Convery, E., Keidser, G., Seeto, M., et al.[2022]

The introduction of hearables and over-the-counter (OTC) hearing aids is expected to significantly change the hearing health care market by addressing the unmet needs of various consumer segments, indicating a large potential market for hearables.

Despite the potential for OTC hearing aids, a survey revealed that about half of current and potential users are uncomfortable managing hearing-related tasks without professional help, suggesting that hearing care professionals will still play a crucial role in the adoption and success of these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology. Edwards, B.[2021]

In a study of 56 participants with varying degrees of hearing loss, personal sound amplification products (PSAPs) performed similarly to basic and premium hearing aids (HAs) for individuals with mild to moderate hearing impairment, suggesting PSAPs could be a cost-effective alternative.

For participants with moderately severe hearing loss, premium HAs significantly outperformed both PSAPs and basic HAs, indicating that more advanced hearing aids are necessary for effective management of severe hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid. Cho, YS., Park, SY., Seol, HY., et al.[2020]

The introduction of over-the-counter (OTC) hearing aids by the FDA aims to improve accessibility and affordability for individuals with age-related hearing loss, addressing barriers like high costs and stigma.

Current research on OTC hearing aids is limited, highlighting the urgent need for independent studies to evaluate their effectiveness and inform clinical practices, especially for individuals with mild-to-moderate hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss. Manchaiah, V., Swanepoel, W., Sharma, A.[2023]

In a study involving 25 older adults with mild-to-moderate hearing loss, audiologist-fitted hearing aids provided significantly better speech recognition and reduced listening effort compared to self-adjusted personal sound amplification products (PSAPs).

While hearing aids offered superior audibility and performance, all PSAPs still improved speech recognition and listening effort compared to no amplification, making them a potential budget-friendly alternative for those unable to afford traditional hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Brody, L., Wu, YH., Stangl, E.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6132942/

The impact of rehabilitation on quality of life after hearing loss The main finding was that hearing rehabilitation is beneficial in all types of hearing loss and treatment regarding quality of life.

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American Speech-Language-Hearing Association Clinical ... AR = aural rehabilitation. To examine the self-perceived difficulties brought about by hearing loss, the hearing disability and perceived disability outcome ...

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Impact of hearing rehabilitation programs on presbycusis ... Conclusion: Hearing rehabilitation programs significantly improve hearing aid outcomes, reduce self-perceived hearing impairment, and alleviate ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6363556/

Evidence-Based Interventions for Adult Aural Rehabilitation The majority agreed the RLOs helped their understanding (97%), held their interest (92%), would be referred to if they had problems with hearing aids (88%), ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/23312165231198380

Effectiveness of Auditory Training in Experienced Hearing ... Results showed that half of the cochlear implant users showed better speech in noise perception and better quality of life following training.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616586/

Outcomes for Hearing Health Interventions - NCBI - NIH Data from a clinical convenience sample of 5,808 patients at Stanford Ear Institute revealed that many patients have significant challenges on the Quick Speech- ...

7. who.int who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss

Deafness and hearing loss Over 5% of the world's population – or 430 million people – require rehabilitation to address their disabling hearing loss (including 34 million children).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05083221

Effect of an Aural Rehabilitation Program in Hearing ... The purposes of this study are to examine the effects of an audiological rehabilitation program (Hear-Talk-Activity audiological rehabilitation program) ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925000598

Effects on health outcomes following a nurse-led hearing ... A 10-week nurse-led Hear-Talk-Activity intervention for older adults with hearing loss was developed, which included health education, psychosocial support, ...